Healthcare Technology Management - A Systematic Approach

Francis Hegarty, John Amoore, Paul Blackett, Justin McCarthy, Richard Scott

• Publisher: CRC Press
• Year: 2017
• ISBN:
  9781315354507
• Edition: 1
• Topic: Negocios y empresa
• Subtopic: Sector de servicios

Healthcare Technology Management: A Systematic Approach offers a comprehensive description of a method for providing safe and cost effective healthcare technology management (HTM). The approach is directed to enhancing the value (benefit in relation to cost) of the medical equipment assets of healthcare organizations to best support patients, clinicians and other care providers, as well as financial stakeholders. The authors propose a management model based on interlinked strategic and operational quality cycles which, when fully realized, delivers a comprehensive and transparent methodology for implementing a HTM programme throughout a healthcare organization. The approach proposes that HTM extends beyond managing the technology in isolation to include advancing patient care through supporting the application of the technology. The book shows how to cost effectively manage medical equipment through its full life cycle, from acquisition through operational use to disposal, and to advance care, adding value to the medical equipment assets for the benefit of patients and stakeholders.

This book will be of interest to practicing clinical engineers and to students and lecturers, and includes self-directed learning questions and case studies. Clinicians, Chief Executive Officers, Directors of Finance and other hospital managers with responsibility for the governance of medical equipment will also find this book of interest and value.

For more information about the book, please visit the website.

CHAPTER 1

Clinical Engineering in the Healthcare System

CONTENTS

1.1 Introduction

1.1.1 What Do We Mean by ‘Medical Devices’, ‘Medical Equipment’ and ‘Healthcare Technology’?

1.1.2 The Context in Which Clinical Engineering Now Operates

1.2 The Health System

1.2.1 Home/Community Care

1.2.2 Primary Care

1.2.3 Secondary Care

1.2.4 Tertiary Care

1.2.5 Healthcare as a Cycle

1.3 The Need for Clinical Engineers in the Healthcare System

1.4 Value in Healthcare

1.5 How Clinical Engineering Adds Value in the Healthcare Delivery Organization

1.5.1 Equipment Management

1.5.2 Advancing and Supporting Care

1.5.3 Healthcare Technology Management: Dual Remit

1.6 Clinical Engineering and Biomedical Engineering

1.6.1 Research and Development of New Medical Equipment

1.6.2 Innovation

1.6.3 Clinical Engineers Contribute to Standards Development

1.6.4 Clinical Engineers Contribute to Post-Market Surveillance

1.6.5 Knowledge Sharing between Clinical Engineers and Equipment Manufacturers

1.7 Foundations of a HTM System within a Healthcare Delivery Organization

1.7.1 Clinical Engineering within the Corporate Structure

1.7.2 Clinical Engineering Leadership

1.7.3 Clinical Engineering Ethics

1.8 Clinical Engineering Advancing Patient Care

1.9 Conclusion

References

Self-Directed Learning

Case Studies

Case Study CS1.1: Planning a New Equipment Support Plan for an Expansion to an Endoscopy Day Unit

Case Study CS1.2: The Clinical Engineer as an Application Support Expert in the ICU

Case Study CS1.3: Ethics and the Clinical Engineer

1.1 INTRODUCTION

Clinical engineering practice emerged to meet a very real need. In the late 1960s and 1970s, the increase in the number, functionality and range of electronic medical equipment used in healthcare brought with it a corresponding need for engineers and technicians to support this equipment which needed regular maintenance and repair. Over time the number and range of equipment continued to proliferate, becoming more complex, and the role of engineers, technologists and technicians based in hospitals evolved to include support for the application of medical equipment as well as its maintenance. Continuing developments in material science, electronics and instrumentation improved the reliability of the medical equipment; however, its complexity continued to increase. Safety was enhanced through the development and adoption of Standards which set out minimum operational and safety requirements for medical equipment which must be met before the item can be placed on the market.

However, the need for vigilance in the use of this equipment, which often makes direct physical connection with patients or delivers energy to patients, remained. Just as the introduction of x-rays into clinical practice resulted in a need to have physicists working in hospitals to develop safe ionizing radiation working practices, so the increase in electronic medical equipment led to the need to have engineers working in healthcare. Initially the priority was for engineers to develop and provide maintenance services both to repair faulty devices and, equally importantly, to ensure that the equipment remained safe and effective through regular maintenance checks and calibration. Whilst essential, this maintenance and repair support was increasingly seen as only meeting part of the requirements for safe and effective applications of medical equipment. By the end of the twentieth century, the role of those who practice clinical engineering had expanded well beyond these maintenance roles to include risk management, support for clinical governance and end user support, contributing to Standards development and contribution to research, development and innovation of new medical equipment, devices and systems. The growing medical equipment industry also needed design and production engineers, together with maintenance staff to repair faulty devices.

Clinical engineering is the name used to describe this specialist strand of engineering which is focused on excellence in the application of technology in the clinical environment. Clinical engineers are experts at solving the problem of complexity in today’s healthcare industry, harnessing and adding value to the application of technology whilst assuring safe and effective healthcare delivery.

1.1.1 What Do We Mean by ‘Medical Devices’, ‘Medical Equipment’ and ‘Healthcare Technology’?

These three terms have been given an internationally agreed meaning, and so for clarity, it is worth reviewing the World Health Organization definitions of the terms medical device, medical equipment and health technology (WHO 2011, p. 4). The term ‘medical device’ is used to describe all items or machines that are used to improve the health of an individual, excluding drugs. The World Health Organization brief definition for a medical device is,

“An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological or metabolic means.”

The term ‘medical equipment’ is used to describe active, powered medical devices and systems deployed to support the delivery of care. The World Health Organization definition for medical equipment is,

“Medical devices requiring calibration, maintenance, repair, user training, and decommissioning – activities usually managed by clinical engineers. Medical equipment is used for the specific purposes of diagnosis and treatment of disease or rehabilitation following disease or injury; it can be used either alone or in combination with any accessory, consumable, or other piece of medical equipment. Medical equipment excludes implantable, disposable or single-use medical devices.”

WHO (2011, p. 4)

The World Health Organization defines ‘health technology’ as

“The application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life. It is used interchangeably with ‘healthcare technology.”

In this book we shall explore a systematic and structured approach to the active management of healthcare technology with the emphasis on devices, equipment, procedures and systems and show how, through this, clinical engineers can add value to the application of medical devices and equipment for patient care.

1.1.2 The Context in Which Clinical Engineering Now Operates

Where once complex medical equipment was confined to the acute care facilities in teaching hospitals, now it is present in all areas of hospitals, in the primary care setting and in the community and patients’ homes. The increasing desire to shift care from hospital institutions into the community is and will continue to be supported by developments in mobile medical equipment. So the need for clinical engineers now extends beyond the walls of the hospital. Wherever the location of patient care, the core purpose of those practising clinical engineering remains the same: to help ensure the availability, at the point of need, of the appropriate technology that is safe, effective and understood by the users.

As medical equipment and its applications develop and expand, these technologies need to be actively managed, and their use supported. Active management includes technical maintenance, professional asset management including life cycle and financial management, expert scientific support for their use at the point of care and vigilance with regard to their safe use. Thus training of users was added to the repertoire of the clinical engineer, helping ensure that the equipment is applied by competent users who understand the equipment. There was also growing awareness that training alone would not suffice to ensure safe and effective equipment application. The equipment must be easy to use, and the role of the clinical engineer has extended to ensure that the importance of human factors was incorporated in industry at the design stage and, within healthcare organizations, when procuring medical equipment. Active management also includes feedback to manufacturers and regulatory agencies of problems detected during operational use, especially human factor aspects such as unanticipated human–device interface and human performance–based failure modes.

In this chapter we will discuss the role of clinical engineers today in the healthcare sector. In doing so we will discuss the context within which they work. The focus will remain on clinical engineering as practiced in hospitals, but the discussion acknowledges that there is a wider and growing role for clinical engineering in all sectors of healthcare. So in many instances where we use the term ‘hospital’, the points we are making apply equally to other parts of the healthcare systems as described in the following text. The discussion will be structured around two themes, namely equipment management and advancing and supporting care. We will also examine some of the other roles played by clinical engineers in supporting research and device regulation. We will see that clinical engineering today still meets a very real and expanding need in the healthcare sector. We identify the important role that clinical engineers play in healthcare delivery, helping organizations to meet the objectives of all their stake holders.

1.2 THE HEALTH SYSTEM

The health system is the collective term used to describe the people, institutions and resources that deliver health services to meet the health needs of the society it serves. The make-up and workings of health systems vary between jurisdictions. In some countries, health system planning is driven by government policy. In others the free market plays a bigger role. The health system is a broad term that encompasses health promotion, health education, disease prevention and the provision of care within the home, community and health institutions. The World Health Organization defines health systems as follows:

“A health system consists of all organizations, people and actions whose primary intent is to promote, restore or maintain health. This includes efforts to influence determinants of health as well as more direct health-improving activities.”

WHO (2007, p. 2)

Health systems are typically viewed from the organizational perspective, but we must remember that healthcare is person focused, and as we describe the sectors of healthcare systems, we will also consider them from the perspective of the patient and the patient’s journey.

Healthcare is the term used to describe the diagnosis, treatment and prevention of illness in society. Healthcare is usually described as consisting of three sectors, primary, secondary and tertiary care. However, considering that practices that promote public health are also included in the term, a fourth sector is necessary and this is healthcare in the community or home setting. In this book we are concerned with how clinical engineers support the delivery of healthcare through the application of technology, with common principles applicable to all sectors. Before discussing the role technology plays, it is useful to discuss the four sectors in more detail.

1.2.1 Home/Community Care

Ideally we would all like to live long healthy independent lives in our own homes, and for most of our lives, we do so. However, all have had the experience of occasionally getting sick with a brief illness like the flu and our family and friends caring for us during this time. Healthcare is provided informally by families and other social networks at home and in the community. Sometimes due to limitations associated with chronic illness or ageing, individuals need a higher level of care. Families may employ care assistants to help look after loved ones in their own homes. Independence can be maintained through the provision of expert care from professionals working in the community, providing home care, aids for independent living or specialist rehabilitation services. Where the illness or dependency is more challenging and beyond the ability of family and carers in the home to manage, individuals may be looked after within special care home facilities within the community. All of these types of activity are described by the term Home/Community Care.

1.2.2 Primary Care

When individuals have exhausted the limits of home healthcare, they consult with a community physician, family doctor or other licensed clinical professional such as a physiotherapist, nurse specialist or pharmacist. This part of the healthcare system is termed primary care. So if you get the flu and it does not clear up after a few days care at home, you may go to your family doctor or pharmacist for a consultation and advice. There is significant intersection between the home/community care and primary care sectors. The elderly and infirm, living at home managing one or more long-term conditions successfully, will no doubt also regularly consult with their primary care physician. These community-based physicians rely on medical devices to diagnose and provide first-line care and treatment. In order to have the best chance of living long healthy independent lives in our own homes, it is desirable where possible that chronic physical, mental and social health issues be managed in the community through a combination of home/community care and primary care. As the cost of healthcare increases, particularly the cost of hospital care, there is a recognition that society needs to invest in primary care to support individuals to continue to live independently in the community as long as possible. This has financial, health and social benefits for the individual and society. This is particularly so given the increase in the number of elderly people living in the more developed nations of the world.

1.2.3 Secondary Care

Secondary care is the term used to describe care provided by medical specialists and usually delivered from within a hospital setting. Typically a primary care practitioner will refer an individual to see a medical specialist. So if you see your family doctor after a week of having the flu, they might refer you to the local hospital for a chest x-ray to see if you have pneumonia. In doing so, you are entering the secondary care sector, and the x-ray will...

Table of contents

• Cover
• Half Title
• Title Page
• Copyright Page
• Contents
• Preface
• Acknowledgments
• Author
• Chapter 1 ▪ Clinical Engineering in the Healthcare System
• Chapter 2 ▪ Taking a Systems Engineering Approach
• Chapter 3 ▪ Key Standards, Regulations and Guidelines
• Chapter 4 ▪ Life Cycle Management of Medical Equipment
• Chapter 5 ▪ The Healthcare Technology Management System: Strategic
• Chapter 6 ▪ Developing Equipment Support Plans in the Context of the HTM Programme
• Chapter 7 ▪ The Extended Role of Clinical Engineers: Advancing Healthcare
• Chapter 8 ▪ The Clinical Engineering Department: Achieving the Vision
• Chapter 9 ▪ Medical Device Governance
• Chapter 10 ▪ Healthcare Technology Management Adding Value
• Glossary
• Index